RADICAL CHANGES

1 November 1999



Quality system standards are undergoing a sweeping review. Jim Lambert explains ISO 9000.


BS 5750 was first published in three parts in 1979 by the British Standards Institution (BSI). The standard was based upon NATO and Ministry of Defence standards, and was primarily aimed for use by manufacturing industry. Unfortunately, the standard’s content retained many military terms and was not very user friendly. Consequently, the three parts of BS 5750 were reviewed and reissued in 1987, with the dual titles of BS 5750 Parts 1, 2 and 3, and their ISO equivalents, ISO 9001, ISO 9002 and ISO 9003.

Equivalent

In the UK, organisations would normally be claiming certification to BS 5750 Part 1, 2 or 3, whereas in the EU and other countries, organisations would claim to be registered to ISO 9001 or ISO 9002 or ISO 9003. All these standards were technically equivalent but the dual titles were proving a problem for international trade.

Under ISO rules, standards must be periodically reviewed and the ISO 9000 series was reissued in 1994. At this point, the title BS 5750 was dropped and the International titles ISO 9001, ISO 9002 and ISO 9003 were adopted worldwide.

The 1994 issues of ISO 9001, ISO 9002 and ISO 9003 – the ISO 9000 series – were still difficult to apply to service organisations, as they retained a structure that leant towards manufacturing industry processes. The main difficulties for service organisations with the ISO 9000 series were the terminology used and the interpretation of the requirements in a service organisation context.

Because of the difficulties in effectively adapting the ISO 9000 series to certain organisation sectors, the national and international standards making bodies – BSI in the UK – decided to completely review the whole ISO 9000 series of (20) standards. The reviewer’s objectives were, to reduce the series to just three primary standards – ISO 9000, ISO 9001 and ISO 9004; to make the standards more accessible and meaningful to all organisations; to ensure that by the correct application of the standards, the needs and expectations of an organisation’s customers would be met.

The review started in 1997 and is now nearing completion. The Draft International Standards will be issued in November 1999 and will be finalised in August 2000. The Standards will be published in November 2000. It is not envisaged that there will be many changes to the Draft International Standard after it is issued. It is recommended that organisations that are already certificated to ISO 9001, 9002 or 9003 should get a copy of the draft standards as soon as they are published. A study of these draft standards will allow an organisation to determine what changes they will need to make to their quality systems to meet the requirements of the revised standards.

The ISO 9000 series will be simplified by reduction into three quality management systems standards. Namely,

• ISO 9000:2000 Quality management system, Fundamentals and vocabulary

• ISO 9001:2000 Quality management system, Requirements

• ISO 9004:2000 Quality management system, Guidance for performance improvement.

It is a proposed that other ISO standards and guidelines for specific issues will support these standards.

The key change is that there will only be one requirement standard – ISO 9001. This will replace the current ISO 9001, ISO 9002 and ISO 9003. So eventually, all organisations and businesses will be certificated and registered as complying with ISO 9001, albeit with reduced scopes. The new standard has been structured to allow its scope to be reduced to meet an organisation’s particular requirements. This change has been necessary to allow ease of use by all organisations, whether they are large or small, private or public, manufacturers or service providers.

The purpose of ISO 9004 is to provide organisations with a process map towards organisation excellence. It is complementary to ISO 9001 and it should help an organisation to plan and implement a system of continual improvement for its management systems.

Compatible

Both ISO 9001 and ISO 9004 are intended to be compatible with the ISO 14000 series of environmental management standards. Facilitating compliance with the requirements of both these standards through one management system.

A process-based approach to quality systems has been adopted in the development of ISO 9001 and ISO 9004. This approach embraces the key quality management system elements that have been identified to ensure that customer needs and expectations will be satisfied. The approach also promotes an organisation culture of continual improvement and organisation excellence.

The key system elements are: A Customer Focused Organisation – an organisation should know the needs and expectations of customers, they should meet those needs both now and in the future, and they should try to exceed those needs and expectations.

   An organisation should recognise the role of leadership and responsibility within top management. Leadership provides the sense of purpose within the organisation and establishes a culture that will satisfy customer needs and expectations, whilst establishing an environment that involves and uses the creative skills of the people it employs.

By involving all its employees, at all levels, in the fulfilment of customer needs and expectations, by clearly specifying their roles and responsibilities, and by making full use of their inherent abilities, an organisation achieves an enormous contribution to the success of its activities.

Management must understand that customer needs and expectations are delivered by a system of interrelated processes, and that the effective management of the system is crucial in achieving both customer satisfaction and organisation success.

Management should recognise that by managing each system process correctly they will achieve the required process result and in the most effective and efficient way.

Establishing mutually beneficial relationships between the organisation and its suppliers facilitate the delivery of customer satisfaction, and have major benefits to both organisations.

Factual approach to decision making: the organisation should gather suitable data and information that affect, or could affect, its operations and then make management decisions that are based upon the sound and common sense analysis of this data and information.

Management should recognise that a philosophy of continual improvement in its products, services, systems and processes is necessary to achieve the sustainability of the organisation.

Application of these principles within an organisation: by the implementation and maintenance of a quality management system based upon ISO 9001:2000 – should ensure the continuing capability of the organisation’s capacity to meet customer needs and expectations, and to ensure the organisation’s long term viability.

The structure of both ISO 9001 and ISO 9004 has undergone a radical change. Both have been drafted so that their clause numbers are coincidental for ease of use. ISO 9004 contains guidance on the above eight quality system elements and can be used for self-assessment purposes.

Although ISO 9001:2000 addresses the twenty key elements/requirements of ISO 9001:1994, the layout of the standard has undergone radical change. There are five main clauses instead of the current twenty clauses. These are supported by sub clauses as in the current ISO 9001. The clause headings are as follows:

• Quality management system

• Management Responsibility • Resource Management

• Product and/or Service Realisation

• Measurement, analysis, and improvement

Although still at a draft stage and subject to review, the revised requirements of ISO 9001 are going to require an organisation’s management to undertake a comprehensive review of its quality management system. This should result in a plan of action on how the revised requirements are to be addressed and met by the organisation. This is the start of the Plan, Do, Study, Act cycle that is essential when an organisation is trying to achieve its objectives.

An in-depth analysis of the actual requirements would be unproductive at this stage of the revision process. However, the following proposed new requirements are highlighted to present management with a feel for what is in store for them.

The draft ISO 9001 requires that:

• top management is committed to the system and to continual improvement.

• organisational changes are effectively controlled.

• customer needs and expectations are understood and met.

• procedures shall be established to measure customer satisfaction with the organisation’s products and services.

• procedures shall be established for internal communications within the organisation and external communications with customers.

• awareness of quality policies and customer requirements shall be communicated throughout the organisation.

• quality objectives are established at each level within the organisation.

• procedures shall be in place to identify legal requirements applicable to the products/services being provided.

• the organisation shall have access to these legal requirements.

• the organisation shall determine and control the processes that produce the customer’s required product or service.

• procedures shall be in place to ensure that employees carrying out quality activities are competent in these activities.

• the organisation shall identify work environmental factors/conditions that affect quality and shall implement these factors/conditions.

• the organisation shall identify and use statistical tools.

• procedures shall be in place to analyse data that will establish the effectiveness of the system.

Many forward-thinking laundry and dry cleaners will already address these requirements within their current quality systems. These organisations should have no difficulties in addressing the new requirements of the revised ISO 9001. However, many organisations have established “minimal” quality systems that just meet the minimum requirements of the current standards. In most cases, these are organisations that have gone for certification as a pure marketing activity – the certificate on the wall syndrome. These organisations are going to face greater difficulties in meeting the requirements of the revised standards.

Radical changes are being made to the ISO 9000 series of quality management system standards. The purpose of quality management systems, i.e. assurance that customer needs and expectations are met by the organisation, is emphasised throughout the standards. In addition, customer satisfaction measures are now a requirement within the standards.

A process-based approach to quality management is being promoted with the emphasis on continual improvement to systems, products and services. All third party certificated quality systems will eventually have to comply with the requirements of ISO 9001, although the scope may be reduced so that it reflects the organisation’s products and/ or services.

Management should start reviewing the proposed changes to the standards so that they can start adapting their current management systems to satisfy the revised requirements.



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